Quality Systems

Vanessa Fachada Oliveira, is a pharmacovigilance manager and EU QPPV at Arriello. She is a qualified pharmacist with knowledge of pharmacovigilance (PV) legislation, and extensive experience in PV, Quality Management and Medical Information. Based in Lisbon, Portugal, Vanessa supports clients both as a PV consulting specialist and as a global EU QPPV/deputy QPPV or LPPV for the local territory. Arriello is a global provider of regulatory affairs and pharmacovigilance solutions and services for pharma and biotech firms primarily in Europe and North America.

Articles

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

Pharmacovigilance Under Scrutiny: Why Companies are Falling Short

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

HJB and Ansun Biopharma Partner on Biologics CMC Development and Manufacturing

Siegfried Schmitt, PhD, is principal consultant withÂ PAREXEL, Siegfried.Schmitt@parexel.com.

An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel.

Computer Systems Validation–a (Un-)Manageable Task?

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

FDA Sends Mylan Warning Letter

is head of Solid Form Services at Lonza Pharma & Biotech and was previously 

principal scientist at Capsugel’s Bend, Oregon facility.

Innovative approaches to drug screening—such as evaluation to identify the optimal solid state of a molecule and in-vitro characterization to establish the optimal solid state of a molecule and the ideal bioavailability-enhancing technology—can help drug developers meet accelerated development timelines while managing risk.

Evaluating Drug Substance–Drug Product Interplay Accelerates Development

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

Compounded Heparin Sodium Recalled

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

The COVID-19 pandemic has highlighted the challenges and complications of sourcing, tracking, and testing materials for pharmaceuticals. Pharmaceutical Technology spoke with Joe DiMartino, Luminata solution manager at ACD/Labs about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.

Data and the Supply Chain

The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.

FDA Publishes Guidance on Antibacterial and Antifungal Drugs

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

Using Analytical Assays to Ensure Biosimilar Quality

Flora J. Keumurian, florak@mit.edu, is program and operations manager, MIT Center for Biomedical Innovation.

Michael E. Wiebe, mewiebe@mit.edu, is lead investigator, CAACB, and principal at Quantum Consulting, MIT Center for Biomedical Innovation.

Jacqueline Wolfrum, jwolfrum@mit.edu, is co-director, Biomanufacturing Program, and director, BioMAN, MIT Center for Biomedical Innovation.

James C. Leung, leungjc@mit.edu, is lead investigator, CAACB, and senior research fellow, MIT Center for Biomedical Innovation.

Anthony J. Sinskey, is faculty director, MIT Center for Biomedical Innovation; Professor of Biology, MIT, asinskey@mit.edu.

Stacy L. Springs, ssprings@mit.edu, is senior director of programs and executive director of Biomanufacturing Initiatives, MIT Center for Biomedical Innovation.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations. 

Quality Assurance/Quality Control